BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 981253 · Received March 5, 2007

    Report

    Report Number
    2020550-2007-00006
    Event Type
    Other
    Date Received
    March 5, 2007
    Date of Event
    January 26, 2007
    Report Date
    March 1, 2007
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FPK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    HOSP CONTACT ALLEGED THAT DOCTOR WAS PERFORMING AN ENDOMETRIAL FIBROID RESECTION WHEN SHE GLANCED AT THE EQUIMAT AFTER HEARING A BEEP, AND SHE NOTICED THAT SCALE READING WENT FROM 125 TO 1700 CC. SHE STATED NO ONE WAS HANDLING MACHINES AT THAT TIME. SURGEON WAS STILL RESECTING AS SHE EXAMINED BOTH THE EQUIMAT AND ENDOMAT; FINALLY SHE TURNED THE EQUIMAT OFF AND THEY WERE "EYE-BALLING" THE FLUID DEFICIT. PROCEDURE WAS COMPLETED. PT RETURNED TO OR LATER DUE TO FLUID RETENTION; THEY CATHERIZED HER AND COLLECTED 1200CC OF FLUID FROM HER BLADDER. PT WAS FEELING BETTER 2 HRS AFTER INITIAL PROCEDURE. THEY KEPT HER OVERNIGHT FOR OBSERVATION AND SHE WAS RELEASED THE NEXT DAY. KARL STORZ FILED AN MDR (2020550-2007-05) ON THE ENDOMAT WHERE FLUID WAS BACKED UP IN THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ EQUIMAT - FLUID MEASUREMENT DEVICE FPK KARL STORZ GMBH & CO. KG 20302020-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other